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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, stationary
510(k) Number K220919
Device Name MULTIX Impact E
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Denise Adams
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Denise Adams
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received03/30/2022
Decision Date 05/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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